FDA.reportPublic FDA data

Hanger Cranial Band

Primary DI
00859065006003
Brand
Hanger Cranial Band
Company
HANGER NATRIONAL LABORATORIES LLC
Model
F8210
Device description
Cranial Remolding Orthosis
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MVAOrthosis, Cranial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVAOrthosis, CranialNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001669000HANGER CRANIAL BANDHanger Orthopedic Group, Inc.2000-12-08MVA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859065006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859065006003008590650060038590650060030859065006003

GMDN Terms#

Term, Definition table
TermDefinition
Cranial orthosisA custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079272629
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859065006041Hanger Cranial BandSymbiont Logistics, LLCMVA2026-05-11
00860013898083TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860013898090Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860015811103TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00859065006034Sprout3DSurestep, LLCMVA2025-02-03
00859065006027Hanger Cranial Band 3DSymbiont Logistics, LLCMVA2024-12-26
B15176210A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176310A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176410A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176510A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176610A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
00196852667895P-PODPPOD Orthotics Inc.MVA2023-11-20
00860010708101Boston BandBoston Brace International, Inc.MVA2023-09-13
B15170309A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170309PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170409A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170409PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170909A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170909PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29